Pfizer Launching Clinical Trial Testing for COVID Pill in Children 6 and Older

by Samantha Whidden
pfizer-launching-clinical-trial-testing-covid-pill-children-6-older

Pharmaceutical company Pfizer announced this week that it is planning to launch clinical trials in order to test its COVID pill in children ages 6 and older.

According to ABC News, Pfizer’s clinical trial will study the effectiveness of its COVID pill, Paxlovid, on young children. The pharmaceutical company is planning to enroll 140 children between the ages of 6 and 17 for the antiviral pill trial. Those enrolling in the trial will be in two different groups. One group will include those who weigh between 44 and 88 pounds. The other group will consist of those who weigh more than 88 pounds. 

Paxlovid was authorized by the U.S. Food and Drug Administration (FDA) for emergency use in December 2020. The pill is for patients ages 12 and older who have mild-to-moderate symptoms. However, the patients must also be at risk of severe illness. 

What We Know:

  • Pfizer states the clinical trial will study the effectiveness of its COVID-19 antiviral pill, called Paxlovid, in young children.
  • The clinic trial is happening just a little over a year after Pfzier’s Paxlovid receives authoritization by the U.S. Food and Drug Administration for emergency use. 
  • Pfizer’s Paxlovid is now available for patients ages 12 and old who have mild-to-moderate symptoms of COVID-19. 
  • Pfizer is enrolling 140 children between the ages of 6 and 17.  

Pfizer Chief Issues Statement About Upcoming Clinic Trial For COVID Pill on Children 

Meanwhile, Mikael Dolsten, Chief Scientific Officer and President of Worldwide Research, Development, and Medical at Pfizer, issued a statement about the upcoming clinic trial.

“Since the beginning of the pandemic, more than 11 million children under the age of 18 in the United States alone have tested positive for COVID-19. Representing nearly 18% of reported cases. And leading to more than 100,000 hospital admissions. There is a significant unmet need for outpatient treatments that can be taken by children and adolescents to help prevent progression to severe illness. Including hospitalization and death.”

The trial is also an open-label, multi-center, single-arm study. Participants in the 44-to-88-pound group will receive the COVID pill (nirmatrelvir/ritonavir 300 mg/100 mg) orally twice daily for five days. Participants in the second group will receive the pill (nirmatrelvir/ritonavir 150 mg/100 mg) orally twice daily for five days.

Pfizer also reports that it is working to develop an age-appropriate formulation for three additional planned cohorts for younger than six years old. It will be enrolling the trial to include the younger age groups. However the data from the ages 6 to 17 trials must be available. 

Clinicialtrals.gov also reports that the Pfizer trial has three locations. This includes Mississippi, South Carolina, and Texas. The estimated primary completion date of the trial is March 4, 2021. This date is also the estimated study completion date.

Outsider.com